Acute Myeloid Leukemia, FLT3-ITD Mutation
Conditions
Brief summary
It is a prospective, non-interventional, open-label study, in order to observe the safety and response in FLT3-ITD mutation positive AML patients who receiving sorafenib as induction, consolidation, salvage, maintenance or alleviative treatment. The duration of the study from June 2014 through May 2019, with the recruitment duration from June 2014 to May 2017. The inclusion criteria is: 1. Definitely diagnosed as AML 2. FLT3-ITD mutation has been confirmed 3. Accepting the prescription of sorafenib
Interventions
None listed
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Definitely diagnosed as AML * FLT3-ITD mutation has been confirmed * Accepting the prescription of sorafenib
Exclusion criteria
* Can not take drugs orally * Can not follow the doctors' advices * Other reasons that investigators considered as contra-indications for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate | up to 2 years |
| Progress-Free Survival | up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | up to 2 years |
| Leukemia-Free Survival | up to 2 years |
| Median time to the onset of sorafenib resistance | up to 2 years |
Countries
China
Contacts
Primary ContactJia Chen, M.D.
Outcome results
None listed